DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
1. Claims 1-3, 5-7, and 17-21 are pending and under examination on the merits.
Claim 4 is cancelled.
Claim 8-16 and 22-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 25, 2026.
Response to Arguments – Objections to the Specification
2. Applicant’s arguments and amendments filed February 25, 2026 have overcome the objections of record.
Response to Arguments – Claim Objections
3. Applicant’s arguments and amendments filed February 25, 2026 have overcome the objections of record.
Claim Objections
4. Claims 5-7 are objected to for the following reasons:
The syntax of claim 5 obscures the antecedent basis of “the following (A) to (C)” is unclear; there are no elements or embodiments (A) to (C) listed in claim 5. If Applicant intends to recite the embodiments (A) to (C) as recited in claim 1, it is recommended Applicant amend “the following (A) to (C) according to claim 1” to “(A) to (C) according to claim 1”.
Dependent claims are included. Appropriate correction is required.
Response to Arguments – Claim Rejections - 35 USC § 112(b)
5. Applicant’s arguments and amendments filed February 25, 2026 have overcome the rejections of record.
Claim 4 is cancelled; therefore, any rejection to the claim have been rendered moot.
Response to Arguments – Claim Rejections - 35 USC § 112(a)
6. Applicant’s arguments and amendments filed February 25, 2026 have been carefully considered but are not found persuasive and do overcome the rejections of record.
Claim 4 is cancelled; therefore, any objections and rejections to the claim have been rendered moot.
Applicant argues primarily that former embodiments have been removed from the claims and the remaining embodiments retain a high enough degree of sequence identity language that one of ordinary skill in the art would readily understand the presently claimed invention as such is provided in such a manner to sufficiently detail said invention. Applicant’s argument is not persuasive for the following reasons.
Though Applicant has deleted the recitations encompassing polynucleotides that hybridize with polynucleotides complementary to the nucleotide sequence of SEQ ID NO:19 or SEQ ID NO:21 under stringent conditions and polynucleotides encoding a genus of proteins comprising SEQ ID NO:20 having any number of amino acid deletions, substitutions, insertions and/or additions of one or more amino acids, the claims remain directed to polynucleotides encoding a genus of proteins with at least 90% identity to SEQ ID NO:20.
As stated previously in the Non-Final action dated 11/26/2025, SEQ ID NOs:19-21 do not appear to be taught by or known in the prior art. The specification does not describe any common structure/feature of the genus of polynucleotides encoding a genus of proteins with at least 90% identity to SEQ ID NO:20 to be associated with the activity of transferring a methyl group to the 4’-position hydroxyl group of flavone C-glycoside. Accordingly, neither Applicant’s disclosure, nor the prior art describes any common structure/feature of the genus and any association to such claimed function. Regarding the description of a representative number of species, using SEQ ID NO:20 as an example, SEQ ID NO:20 is a polypeptide sequence of 356 amino acids. For at least 90% sequence identity, 10%, or 35 amino acids, can be substituted, deleted or inserted, by 19 different amino acids. Thus, the claimed genus has at least (35+34+33+....+3+2+1) x 19 species when considering substitutions only. In addition, the genus of peptides can range in length from 321 to 391 amino acids long. Accordingly, one of ordinary skill in the art would not be able to readily identify functional embodiments among the broad pool of embodiments claimed by Applicant. MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). When there is substantial variation within a genus, as here in which the genus comprises over (35+34+33+....+3+2+1) x 19 distinct species, one must describe a sufficient variety of species to reflect the variation within the genus. A single amino acid sequence with no indication of the regions required for the desired functionality does not provide adequate written description for all such polypeptides having 90% sequence identity to SEQ ID NO:20.
Accordingly, the claims still lack adequate written description to convey possession of the claimed invention commensurate in scope with the claims and, therefore, remain rejected.
Applicant did not provide an argument addressing the rejection of claims 6-7 due to the lack of adequate written description to provide sufficient details to identify homologs of SEQ ID NO:1-2, wherein said polynucleotides form a protein with the activity of transferring a methyl group to the 7-position hydroxyl group of flavone C-glycoside. Accordingly, the claims still lack adequate written description and, therefore, remain rejected.
Claim Rejections - 35 USC § 112(a)
7. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
8. Claims 1-2, 5-7, and 17-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
To claim a genus under the written description requirement, the applicant is required to describe a representative number of species to reflect the variation within the genus or structures sufficient to define the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combinations thereof. By court’s statement in Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), a written description of an invention “requires a precise definition, such as a structure, formula, or chemical name, of the claimed subject matter sufficient to distinguish it from other materials”; further, a written description of a claimed genus requires a description of a representative number of species of the claimed genus, and one of skill in the art should be able to “visualize or recognize the identity of the members of the genus”.
Claim 1 is broadly drawn to a genus of polynucleotides encoding a genus of proteins with at least 90% identity to SEQ ID NO:20. The function as claimed is encoding a protein having activity of transferring a methyl group to the 4’-position hydroxyl group of flavone C-glycoside. The dependent claims are broadly drawn to a genus of proteins, vectors, plants, and plant parts comprising the broad genus of polynucleotides, as well as the progenies of said plants.
Applicant discloses the structure of SEQ ID NOs:19-21 in the Sequence Listing. The Specification also discloses that SEQ ID NOs:19 and 21 represent cDNA that encode flavone 4-O-methyltransferase (F4OMT) cloned from an mRNA library of Iris japonica sequences (pp. 23-27, Examples 3-4). Examples 5-10 demonstrate changes in flower pigmentation in plants expressing SEQ ID NO:19/SEQ ID NO:21 with a combination of genes encoding F3’5’H (flavonoid 3',5'-hydroxylase), F2H (flavanone 2- hydroxylase), CGT (flavone C-glycosyltransferase), FNS (flavone synthase), FDH (flavone dehydratase), and/or F7OMT (flavanone-7-O-methyltransferase).
Both Applicant’s disclosure[0012] and the Examiner’s sequence search indicate that SEQ ID NO:20 is not taught by or known in the prior art. The specification does not describe the common structure/feature of the genus of polynucleotides encoding a genus of proteins with at least 90% identity to SEQ ID NO:20 to be associated with the activity of transferring a methyl group to the 4’-position hydroxyl group of flavone C-glycoside. Accordingly, neither Applicant’s disclosure, nor the prior art describes any common structure/feature of the genus and any association to such claimed function.
Issue 1: Regarding claim 1, Applicant has not disclosed sufficient details to identify polynucleotides encoding a genus of proteins having only 90% sequence identity to SEQ ID NO:20, wherein said polypeptides form a protein with the activity of transferring a methyl group to the 4’-position hydroxyl group of flavone C-glycoside.
Regarding claim 1, polynucleotides encoding a genus of proteins with at least 90% identity to SEQ ID NO:20 encompass a broad number of amino acid deletions, substitutions, and/or additions, wherein the positions of said deletions, substitutions, and/or additions are not specified. The specification does not describe or mention any conserved, required, or sufficient domain(s) of SEQ ID NO:20 that is associated with the activity of transferring a methyl group to the 4-position hydroxyl group of flavone C-glycoside. SEQ ID NO:20 is a newly discovered protein, thus, prior art does not describe or mention any conservative domain(s) of SEQ ID NO:20 that is associated with the activity of transferring a methyl group to the 4’-position hydroxyl group of flavone C-glycoside. Accordingly, the deletions, substitutions, and/or additions of such amino acids can disrupt the conservative domain(s), which would inhibit the activity of transferring a methyl group to the 4’-position hydroxyl group of flavone C-glycoside.
The specification indicates the sequence identities and functions of putative flavone methyltransferases were identified using NCBI’s BLAST and function annotations[0056] (pp. 23-24, Example 3). However, Friedberg (Bioinformatics. 2006; 7:225-242 (previously cited)) teaches that homology-based transfer is not reliable for functional annotation even with high degrees of sequence similarity, that identification of functionally significant sub-regions is critical to functional annotation, and that often addition, deletion, or re-shuffling of domains can lead to errors in annotation (Abstract; p. 227, right column, second paragraph; p. 229, left column, first partial paragraph). Friedberg teaches that sequence-based tools are not sensitive enough to identify functional protein similarity as databases get larger, and diversity of sequences gets larger (p. 229, left column, first full paragraph). Additionally, Wang et al (Ieee/Acm Transactions On Computational Biology And Bioinformatics. 2017; 14(3):503-513 (previously cited)) teach that FASTA and Basic Local Alignment Search Tool (BLAST) are useful but have limitations because a duplicate of a gene could adopt a new function in response to selective pressure during evolution, function transfer by homology to such gene and its product could produce erroneous results (p. 503, left column, second paragraph). Moreover, genes evolve at different rates due to both uneven selection pressure on their functions and the inherent mutation rate of different species, which means that it is difficult to establish a similarity measure that is reliable in all cases and the prior art does not indicate which criterion and which algorithm is optimal for protein function prediction (p. 504, left column, 1st para). Thus, one of ordinary skill in the art would not be able to predict, with any reasonable expectation of success, which sequences encompassed by the claims form functional proteins with the activity of transferring a methyl group to the 4-position hydroxyl group of flavone C-glycoside.
Regarding the description of a representative number of species, using SEQ ID NO:20 as
an example, SEQ ID NO:20 is a polypeptide sequence of 356 amino acids. For at least 90%
identical, 10%, or 35 amino acids, can be substituted, deleted or inserted, by 19 different amino
acids. Thus, the claimed genus has at least (35+34+33+....+3+2+1) x 19 species for substitution
only. In addition, the genus of peptides can be from 321 to 391 amino acids long. Given that the position of the one or more amino acids and numbers of such deletions, substitutions, insertions and/or additions of such amino acids are not specified, such deletions, substitutions, insertions and/or additions encompass more than 10% thereof, thus, is even broader than that of at least 90% identical. Given that the hybridizing polynucleotide sequences are not required to have 100% sequence identity to the recited sequence, said hybridizing sequences encompass sequences with different lengths and differing degrees of sequence identity to the recited sequence.
Applicant claims an extremely large number of species that are heterologous in structure and not likely associated to the activity of transferring a methyl group to the 7-position hydroxyl group of flavone C-glycoside. The working examples comprise SEQ ID NOs:19-21 in their entirety and the specification does not indicate any residues or regions within SEQ ID NOs:19-21 that are dispensable to the function encoded therein. Thus, SEQ ID NOs:19-21 are not sufficient to represent the claimed genus of sequences as broadly claimed. Accordingly, there is lack of adequate written description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing.
Accordingly, there is lack of adequate written description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. Because dependent claims 2, 5-7 and 17-21 do not address the deficiencies regarding sequences having only 90% sequence identity to SEQ ID NO:20, they also lack adequate written description.
Issue 2: Regarding claims 6-7, Applicant has not disclosed sufficient details to identify homologs of SEQ ID NO:1-2, wherein said polynucleotides form a protein with the activity of transferring a methyl group to the 7-position hydroxyl group of flavone C-glycoside.
Regarding homologs of the genes recited in the dependent claims, as analyzed above, the
specification only describes the plants expressing the combination of SEQ ID NOs:1, 3, 5, 7, 9, 12, 14, 16, 19, 21, and/or 22. The specification does not describe any homolog or genus of homologs of SEQ ID NOs:1, 3, 5, 7, 9, 12, 14, 16, 19, 21, and/or 22 that leads to the activity of transferring a methyl group to the 7-position hydroxyl group of flavone C-glycoside. The prior art does not describe any homolog of SEQ ID NOs:1, 3, 5, 7, 9, 12, 14, 16, 19, 21, and/or 22 that leads to the activity of transferring a methyl group to the 7-position hydroxyl group of flavone C-glycoside.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). When there is substantial variation within a genus, one must describe a sufficient variety of species to reflect the variation within the genus. Two polypeptides with the activity of transferring a methyl group to the 7-position hydroxyl group of flavone C-glycoside do not provide adequate written description for all such polypeptides.
Accordingly, there is lack of adequate written description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing.
Response to Arguments – Claim Rejections - 35 USC § 101
9. Applicant’s arguments and amendments filed February 25, 2026 have been carefully considered but are not found persuasive and do not overcome the rejections of record.
Claim 4 is cancelled; therefore, any rejection to the claim have been rendered moot.
In traversing the rejection, Applicant argues that the claims are directed to cDNA, which does not exist in nature.
Applicant’s argument is not persuasive because even though the cDNA of SEQ ID NOs:19 and 21 are not found in nature, the claims are not limited to SEQ ID NOs:19 and 21; the claims also encompass polynucleotides encoding a protein comprising SEQ ID NO:20. The specification indicates SEQ ID NOs:19 and 21 were cloned from the naturally-occurring mRNA of I. japonica without further modification (pp. 23-27, Examples 3-4). Therefore, the polypeptide encoded by SEQ ID NOs:19 and 21 is identical to the polypeptide encoded by the naturally-occurring I. japonica sequences from which SEQ ID NOs:19 and 21 were cloned. The polypeptide sequences encoded by SEQ ID NOs:19 and 21 share 100% sequence identity with SEQ ID NO:20. Because the polypeptides encoded by SEQ ID NOs:19 and 21 are identical to those encoded by naturally-occurring I. japonica mRNA sequences and the polypeptides encoded by SEQ ID NOs:19 and 21 are identical to SEQ ID NO:20, SEQ ID NO:20 is identical to a naturally-occurring polypeptide encoded by sequences naturally-occurring in I. japonica. Thus, polynucleotides encoding proteins comprising the amino acid sequence of SEQ ID NO:20 encompass naturally-occurring sequences and are not patent-eligible.
Accordingly, claims 1, 3, and 17-21 remain rejected under 35 USC § 101.
Claim Rejections - 35 USC § 101
10. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
11. Claims 1, 3, 17, and 20-21 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to a product(s) of nature without significantly more.
In Association for Molecular Pathology v. Myriad Genetics, Inc., --U.S.--(June 13, 2013), the Supreme Court decided that a naturally-occurring nucleic acid or fragment thereof, whether isolated or not, is not patent-eligible. Therefore, naturally-occurring products, including proteins, are not patent-eligible.
The specification indicates SEQ ID NOs:19 and 21 were cloned from the naturally-occurring mRNA of I. japonica without further modification (pp. 23-27, Examples 3-4). Therefore, the polypeptide encoded by SEQ ID NOs:19 and 21 is identical to the polypeptide encoded by the naturally-occurring I. japonica sequences from which SEQ ID NOs:19 and 21 were cloned. Analysis of the polypeptide sequences encoded by SEQ ID NOs:19 and 21 indicate that said sequences share 100% sequence identity with SEQ ID NO:20. Because the polypeptides encoded by SEQ ID NOs:19 and 21 are identical to those encoded by naturally-occurring I. japonica mRNA sequences and the polypeptides encoded by SEQ ID NOs:19 and 21 are identical to SEQ ID NO:20, SEQ ID NO:20 is identical to a naturally-occurring polypeptide encoded by sequences naturally-occurring in I. japonica. Thus, polynucleotides encoding proteins comprising the amino acid sequence of SEQ ID NO:20 encompass naturally-occurring sequences and are not patent-eligible. Accordingly, claims 1 and 3 are not patent-eligible.
Claim 17 recites an outbred progeny of a transgenic plant comprising a polynucleotide of claim 1. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the polynucleotide of claim 1 encompasses natural products, as discussed above, and the claims do not recite or place additional limitations on the transgenic plant. Therefore, said progeny includes plants that would be genetically identical to, and thus, not markedly different from, wildtype (i.e., naturally-occurring) plants. Therefore, claim 17 encompasses products of nature and/or products not markedly different from products of nature and is not patent-eligible.
Claim 20 limits the claimed product to the propagules, partial plant bodies, tissues, or cells of the recited plant. Claim 21 limits the claimed product to cut flowers of the recited plant. However, neither of these limitations adds significantly more to distinguish the claimed products from products of nature because naturally-occurring plants comprise propagules, partial plant bodies, tissues, cells, and flowers. Therefore, claims 20-21 encompass products of nature and/or products not markedly different from products of nature and are not patent-eligible.
Response to Arguments – Claim Rejections - 35 USC § 102
12. Applicant’s arguments and amendments filed February 25, 2026 have overcome the rejections of record.
Claim 4 is cancelled; therefore, any rejection to the claim have been rendered moot.
Conclusion
13. No claim is allowed. The closest prior art, Schroder et al. (Phytochemistry. 2004; 65(8):1085-1094 (previously cited)), teaches a vector comprising a polynucleotide encoding a protein having the activity of transferring a methyl group to the 4’-position hydroxyl group of flavone C-glycoside (Abstract). Schroder is silent to SEQ ID NOs:19-21.
14. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner’s Contact Information
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571)-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
Prosecution Insights